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Align Technology Inc recalls Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Recalled February 1, 2023 · FDA recall Z-1017-2023 · Align Technology
Hazard
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided. · FDA Class II
Units
14 cases (637 aligner and temples)
Sold at
U.S. Nationwide distribution in the states of AZ, CA, CO, FL, KY, MA, NJ, NY, OH, OK, and WI.
Description
3D orthodontic planning software has a defect that leads to an issue where incorrect number of aligners may be produced (less or greater than the doctor requested) and incorrect packaging is provided.
Product
Invisalign Express 10 REF 8512 Invisalign System Comprehensive REF 9000 Invisalign System Moderate REF 9001
Manufacturer(s)
Align Technology Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →